Medical Editor: John P. Cunha, DO, FACOEP
Twinrix (hepatitis A inactivated and hepatitis B [recombinant]) Vaccine is indicated for active immunization of persons 18 years of age and older against disease caused by hepatitis A virus, and infection by all known subtypes of hepatitis B virus. As with any vaccine, vaccination with Twinrix may not protect 100% of recipients. As hepatitis D (caused by the delta virus) does not occur in the absence of hepatitis B infection, it can be expected that hepatitis D will also be prevented by vaccination with Twinrix. Like any medicine, Twinrix vaccine can cause side effects, but the risk of serious side effects is extremely low. Becoming infected with hepatitis A or B is much more dangerous to your health than receiving Twinrix vaccine to protect against these diseases. Side effects of Twinrix include:
- injection site reactions (redness, pain, tenderness, swelling, or a hard lump),
- sore throat,
- runny or stuffy nose,
- other cold symptoms,
- tired feeling,
- loss of appetite, or
Tell your doctor if you have rare but serious side effects of Twinrix including:
- fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
- fast or pounding heartbeats; or
- easy bruising or bleeding.
Twinrix contains 720 ELISA units of inactivated hepatitis A virus and 20 mcg of recombinant HBsAg protein per ml. Twinrix should be administered by intramuscular injection. Do no inject intravenously or intradermal. In adults, the injection should be given in the deltoid region. Twinrix should not be administered in the gluteal region; such injections may result in a suboptimal response. When concomitant administration of other vaccines or immunoglobulin (IG) is required, they should be given with different syringes and at different injection sites. There have been rare reports of anaphylaxis/anaphylactoid reactions following routine clinical use of Twinrix. Twinrix can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Twinrix should be given to a pregnant woman only if clearly indicated. Because many drugs are excreted in human milk, caution should be exercised when Twinrix is administered to a woman who is breastfeeding. Safety and effectiveness of Twinrix has not been established in the pediatric population.
Our Twinrix (hepatitis A inactivated and hepatitis B [recombinant]) Vaccine Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shot caused any side effects.
You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.
Becoming infected with hepatitis is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.
You may feel faint after receiving this vaccine. Some people have had seizure like reactions after receiving this vaccine. Your doctor may want you to remain under observation during the first 15 minutes after the injection.
Call your doctor at once if you have:
- numbness, tingling, or burning pain;
- red or blistering skin rash with burning or tingly feeling;
- easy bruising or bleeding (nosebleeds, bleeding gums); or
- unexplained muscle pain, tenderness, or weakness.
Common side effects include:
- redness, tenderness, or a hard lump where the shot was given;
- headache; or
- tired feeling.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.
Read the entire detailed patient monograph for Twinrix (Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine)
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. As with any vaccine, there is the possibility that broad use of TWINRIX could reveal adverse events not observed in clinical trials.
Following any dose of TWINRIX, the most common ( ≥ 10%) solicited injection site reactions were injection site soreness (35% to 41%) and redness (8% to 11%); the most common solicited systemic adverse events were headache (13% to 22%) and fatigue (11% to 14%).
The safety of TWINRIX has been evaluated in clinical trials involving the administration of approximately 7,500 doses to more than 2,500 individuals.
In a US study, 773 subjects (18 to 70 years of age) were randomized 1:1 to receive TWINRIX (0-, 1-, and 6-month schedule) or concurrent administration of ENGERIX-B (0-, 1-, and 6-month schedule) and HAVRIX (0- and 6-month schedule). Solicited local adverse reactions and systemic adverse events were recorded by parents/guardians on diary cards for 4 days (days 0 to 3) after vaccination. Unsolicited adverse events were recorded for 31 days after vaccination. Solicited events reported following the administration of TWINRIX or ENGERIX-B and HAVRIX are presented in Table 1.
Table 1: Rates of Local Adverse
Reactions and Systemic Adverse Events Within 4 Days of With or ENGERIX-B and
|Dose 1||Dose 2||Dose 3||Dose 1||Dose 2||Dose 3||Dose 1||Dose 2|
|(N = 385) %||(N = 382) %||(N = 374) %||(N = 382) %||(N = 376) %||(N = 369) %||(N= 382) %||(N = 369) %|
|Systemic||TWINRIX||ENGERIX-B and HAVRIX|
|Dose 1||Dose 2||Dose 3||Dose||Dose||Dose|
|(N = 385) %||(N = 382) %||(N = 374) %||(N = 382) %||(N = 376) %||(N= 369) %|
|aWithin 4 days of vaccination defined as day
of vaccination and the next 3 days.
b389 subjects received at least 1 dose of TWINRIX.
c384 subjects received at least 1 dose each of ENGERIX-B and HAVRIX.
dDoses 1 and 3 included ENGERIX-B and HAVRIX in the control group receiving separate vaccinations.
eDose 2 included only ENGERIX-B in the control group receiving separate vaccinations.
Most solicited local adverse reactions and systemic adverse events seen with TWINRIX were considered by the subjects as mild and self-limiting and did not last more than 48 hours.
In a clinical trial in which TWINRIX was given on a 0-, 7-, and 21- to 30-day schedule followed by a booster dose at 12 months, solicited local adverse reactions or systemic adverse events were comparable to those seen in other clinical trials of TWINRIX given on a 0-, 1-, and 6-month schedule.
Among 2,299 subjects in 14 clinical trials, the following adverse events were reported to occur within 30 days following vaccination:
Incidence 1% to 10% of Injections, Seen in Clinical Trials With TWINRIX
Infections and Infestations: Upper respiratory tract infections.
General Disorders and Administration Site Conditions: Injection site induration.
Incidence < 1% of Injections, Seen in Clinical Trials With TWINRIX
Infections and Infestations: Respiratory tract illnesses.
Metabolism and Nutrition Disorders: Anorexia.
Psychiatric Disorders: Agitation, insomnia.
Ear and Labyrinth Disorders: Vertigo.
Vascular Disorders: Flushing.
Gastrointestinal Disorders: Abdominal pain, vomiting.
Incidence < 1% of Injections, Seen in Clinical Trials With HAVRIX and/or ENGERIX-B:
Blood and Lymphatic System Disorders: Lymphadenopathy.a+b
Nervous System Disorders: Dysgeusia,a hypertonia,atingling.b
Eye Disorders: Photophobia.a
Vascular Disorders: Hypotension.b
Gastrointestinal Disorders: Constipation.b
Investigations: Creatine phosphokinase increased.a
a+b Following either HAVRIX or ENGERIX-B.
a Following HAVRIX.
b Following ENGERIX-B.
Adverse events within 30 days of vaccination in the US clinical trial of TWINRIX given on a 0-, 7-, and 21- to 30-day schedule followed by a booster dose at 12 months were comparable to those reported in other clinical trials.
The following adverse events have been identified during postapproval use of TWINRIX, HAVRIX, or ENGERIX-B. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to product exposure.
Experience with TWINRIX
The following list includes serious events or events which have suspected causal connection to components of TWINRIX.
Blood and Lymphatic System Disorders: Thrombocytopenia, thrombocytopenic purpura.
Immune System Disorders: Allergic reaction, anaphylactoid reaction, anaphylaxis, serum sickness-like syndrome days to weeks after vaccination (including arthralgia/arthritis, usually transient, fever, urticaria, erythema multiforme, ecchymoses, and erythema nodosum).
Nervous System Disorders: Bell's palsy, convulsions, encephalitis, encephalopathy, Guillain-Barr� syndrome, hypoesthesia, myelitis, multiple sclerosis, neuritis, neuropathy, optic neuritis, paralysis, paresis, transverse myelitis.
Eye Disorders: Conjunctivitis, visual disturbances.
Vascular Disorders: Vasculitis.
Gastrointestinal Disorders: Dyspepsia.
Musculoskeletal and Connective Tissue Disorders: Arthritis, muscular weakness.
General Disorders and Administration Site Conditions: Chills, immediate injection site pain, stinging, and burning sensation, injection site reaction, malaise.
Investigations: Abnormal liver function tests.
Experience With HAVRIX and/or ENGERIX-B
The following list includes serious events or events which have suspected causal connection to components of HAVRIX and/or ENGERIX-B, not already reported above for TWINRIX.
Eye Disorders: Keratitis.b
Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome.b
Congenital, Familial and Genetic Disorders: Congenital abnormality.a
a Following HAVRIX.
b Following ENGERIX-B.
Read the entire FDA prescribing information for Twinrix (Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine)
© Twinrix Patient Information is supplied by Cerner Multum, Inc. and Twinrix Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.